FDA.reportPublic FDA data

Hydroxyzine Hydrochloride

Product NDC
43063-962
Requested package NDC
43063-962-95
11-digit product format
430630962
Labeler code
43063
Product ID
43063-962_415f3642-ef05-3671-e063-6294a90ab7a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyzine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040787
Marketing category
ANDA
Marketing start
2012-07-24
Substance
HYDROXYZINE DIHYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Hydroxyzine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROXYZINE DIHYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
76755771U3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
995218Internal RxNorm lookup
995258Internal RxNorm lookup
995281Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1a3e389f-391d-4f37-9e34-ce3c6f5fe8c1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
57311cfb-679a-da1a-b70c-8757f7fc431aProduct name420250516
aa1826f4-97c1-4705-bdf0-3bc7d234e618Product name220190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41Product name120151110
3ca5f78b-43dc-30fe-8014-55b922af52b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-962-01Hydroxyzine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10022
43063-962-82Hydroxyzine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50022
43063-962-95Hydroxyzine Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-962-01EA - Each43063-96236610d3c-d2b1-45f5-9eb5-6d33532ff11d12019-05-02
43063-962-82EA - Each43063-9622a0f3f26-249c-49a7-8ad0-88997557738a12019-05-02
43063-962-95EA - Each43063-96262980039-b064-4b1a-81d5-1f08c983af5012019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-962HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 3 package rows20241018_1a3e389f-391d-4f37-9e34-ce3c6f5fe8c1.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.aa9523e0-c95d-4213-b213-96170d8555362026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040787
application number: ANDA040787
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1a3e389f-391d-4f37-9e34-ce3c6f5fe8c12025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040787
application number: ANDA040787
ndc (package): 43063-962-95
ndc (product): 43063-962
ndc11 (package): 43063096295
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.24cb9c83-a7e4-4bae-997c-c3a87426f78c2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040787
application number: ANDA040787

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995218hydrOXYzine HCl 10 MG Oral TabletPSN1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995258hydrOXYzine HCl 25 MG Oral TabletPSN1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995281hydrOXYzine HCl 50 MG Oral TabletPSN1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995218hydroxyzine hydrochloride 10 MG Oral TabletSCD1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995258hydroxyzine hydrochloride 25 MG Oral TabletSCD1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122
995281hydroxyzine hydrochloride 50 MG Oral TabletSCD1a3e389f-391d-4f37-9e34-ce3c6f5fe8c122

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-962-95430630962951000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-962-95) 2019-04-010000-00-00NoNoCurrent